Job Description:
A Quality Management Systems Project Manager is required to oversee a 12-month contract position in Dublin.
Key Responsibilities
* Develop and manage project plans, timelines, and objectives.
* Collaborate with internal and external stakeholders to ensure all milestones are met.
* Identify, manage, and mitigate project risks and issues.
* E nsure compliance with EUDAMED regulations by coordinating data submissions.
* Provide guidance on EUDAMED-related compliance matters and stay updated on regulatory changes.
* Collaborate with quality assurance, IT, and other departments to integrate and operate EUDAMED processes seamlessly.
Requirements
* Bachelor's Degree in Engineering or a related technical field (minimum of 10 years' experience).
* Experience working in FDA and European regulatory environments preferred.
* Relevant experience in manufacturing/operations required.
* In-depth knowledge of product/process Risk Management (FDA and ISO standards) essential.
* Proven track record of implementing risk mitigation strategies.
* Technical training in Statistics, Lean, and Six Sigma Methodologies (including Measurement System Analysis, SPC, DOEs, Reliability) preferred.